Mixed DyslipidemiaNCT06204380
An Observational Study on the Identification of Prescription Patterns of STAFEN Cap
An observational study of Mixed Dyslipidemia, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
An observational study on the identification of prescription patterns of STAFEN Cap., changes in blood lipid concentration, and statin-related muscle symptoms in Korean patients with mixed dyslipidemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mixed Dyslipidemia
- How many people
- 4,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Apr 2021to 30 Nov 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients Prescribed STAFEN Cap. for the Treatment of Mixed Dyslipidemia
Who may be able to join
- Adults over 19 years of age
- A patient diagnosed with mixed dyslipidemia
- A patient who was first prescribed a STAFEN cap. for the purpose of treating mixed dyslipidemia according to the clinician's judgment
- A patient who voluntarily agreed in writing to this study
Who cannot join
- Pregnant women, lactating women, or those planning to conceive
- A person who is prohibited from administering the STAFEN cap. under the permit
- If the person in charge of other clinical studies and the person in charge deems it inappropriate to be the subject of this clinical study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Delphoe Clinic
Gangneung-si
Heebaek NA Park, 01055279616
About this study
Official title: An Observational Study on the Identification of Prescription Patterns of STAFEN Cap., Changes in Blood Lipid Concentration, and Statin-related Muscle Symptoms in Korean Patients With Mixed Dyslipidemia
An observational study on the identification of prescription patterns of STAFEN Cap., changes in blood lipid concentration, and statin-related muscle symptoms in Korean patients with mixed dyslipidemia
Read the detailed description
This study aims to observe the effectiveness of STAFEN capsule such as changes in blood lipid concentration and safety including statin-related muscle symptoms, and prescription patterns under daily clinical treatment in patients who have been prescribed STAFEN capsules for the treatment of complex dyslipidemia.
- Conditions
- Mixed Dyslipidemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Target triglyceride rate at 6 months of STAFEN capsule prescription compared to baseline
Target triglyceride rate at 6 months of STAFEN capsule prescription compared to baseline
Measured: at 6 months of STAFEN capsule prescription compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start21 Apr 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heebaek Park, Principal investigator, delphoe clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204380
- Sponsor's protocol ID
- HL-STAF-401
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Identification of Prescription Patterns of STAFEN Cap., Changes in Blood Lipid Concentration, and Statin-related Muscle Symptoms in Korean Patients With Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT06204380
- Acronym / sponsor ID
- HL-STAF-401
- Conditions
- Mixed Dyslipidemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study on the identification of prescription patterns of STAFEN Cap., changes in blood lipid concentration, and statin-related muscle symptoms in Korean patients with mixed dyslipidemia
Detailed description
This study aims to observe the effectiveness of STAFEN capsule such as changes in blood lipid concentration and safety including statin-related muscle symptoms, and prescription patterns under daily clinical treatment in patients who have been prescribed STAFEN capsules for the treatment of complex dyslipidemia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Prescribed STAFEN Cap. for the Treatment of Mixed Dyslipidemia
Key inclusion criteria (4 listed)
- Adults over 19 years of age
- A patient diagnosed with mixed dyslipidemia
- A patient who was first prescribed a STAFEN cap. for the purpose of treating mixed dyslipidemia according to the clinician's judgment
- A patient who voluntarily agreed in writing to this study
Key exclusion criteria (3 listed)
- Pregnant women, lactating women, or those planning to conceive
- A person who is prohibited from administering the STAFEN cap. under the permit
- If the person in charge of other clinical studies and the person in charge deems it inappropriate to be the subject of this clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target triglyceride rate at 6 months of STAFEN capsule prescription compared to baseline
Time frame: at 6 months of STAFEN capsule prescription compared to baseline
Target triglyceride rate at 6 months of STAFEN capsule prescription compared to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heebaek Park principal investigator
delphoe clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mixed Dyslipidemia, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heebaek Park (01055279616, thyroid62@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target triglyceride rate at 6 months of STAFEN capsule prescription compared to baseline (time frame: at 6 months of STAFEN capsule prescription compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.